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Quality/Compliance Technical Support Lead (m/f)

MSD Animal Health
Unterschleißheim

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
For our Animal Health production site in Unterschleißheim near Munich we are currently looking for a highly qualified
Quality/Compliance Technical Support Lead (m/f)
Position overview:
Responsible for providing strategic support to MSD Animal Health Small Molecules sites relative to technical quality activities including projects, product & method development, remediation, and transfer and raw materials.
Support the sites in performing significant investigations by ensuring that scientific problem solving is used and ensuring that all the facts are gathered to be presented in appropriate above site forum for evaluation and concurrence of investigation, CAPAs and recommendation for disposition or other actions.
Support the sites in regulatory and corporate audits preparation by coaching the site team in combination with the SQHs and challenging systems.
Identifying resource needs and/or technical knowledge gaps that require attention in order to meet strategic business objectives and utilizing SME’s available in the Quality and in the Technical Support department as necessary with respect to Aseptic Excellence (MSD Aseptic Sterile Standards), Computer Systems Validation, Engineering activities, and Quality Systems.
Author and review technical reports/position papers in support of batch disposition and root cause investigations resulting from Management Notifications or other process or analytical deviations that impact product supply. Develop draft MMD policies, procedures and guidelines to assure alignment with Global Quality areas.
Act as liaison on important quality and regulatory challenges between sites and above site functions as appropriate.
The role will involve a significant amount of travelling to MSD Animal Health sites to provide the support requested. Travelling can reach the level of 40-50% of the working time.
Your profile:
Bachelor degree in Chemistry, Pharmacy, Biology, Chemical Engineering or related science discipline; advanced degree desirable
Minimum 10 years of experience in the Pharmaceutical Industry with Quality and Compliance background
Experience in Human Health aseptic and FDA-regulated manufacturing sites is preferred.
Good level expertise of FDA-regulated aseptic manufacturing processes experience
Strong knowledge and understanding of cGMP regulations, FDA regulations, guidelines and expectations and their application in daily operations
Expert knowledge of Quality Systems, Laboratory processes and equipment, Computer System Validation, Quality Assurance, Quality Control, data integrity concepts; experience in SAP is preferred
Experience in site-based manufacturing and quality operations managerial roles, experience at multiple sites and across multiple functions is preferred
Strong analytical and problem solving as well as coaching skills, extensive knowledge of GMPs and ability to make decisions in a constantly changing environment
Proficient in technical writing in English and current computer usage (Word, Excel, PowerPoint, etc.)
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Our company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.
Interested? Please visit our website for further information: www.msd-tiergesundheit.de.
We are looking forward to receiving your application (CV in English, motivation letter, testimonials, certificates). APPLY NOW!